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Epidural Calcitonin in Lower Limb Amputation

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ClinicalTrials.gov Identifier: NCT02115360
Recruitment Status : Completed
First Posted : April 16, 2014
Last Update Posted : August 31, 2016
Sponsor:
Information provided by (Responsible Party):
Ayman Abd Al-maksoud Yousef, Tanta University

Brief Summary:
A prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

Condition or disease Intervention/treatment Phase
Amputation Stumps Drug: Calcitonin Drug: Fentanyl Not Applicable

Detailed Description:
a cohort of sixty patients of both genders, physical status American Society of Anaesthesiologist (ASA) I and II who will undergo lower limb amputation, will be enrolled into the present study. Patients will divided randomly into two equal groups: Epidural Bupivacain-Calcitonin and fentanyl (BC) Group and Bupivacain- fentanyl (BF) Group, comprising of 30 patients each.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Pre-emptive Value of Epidural Calcitonin in Patients With Lower Limb Amputation. A Double Blinded Randomized Study
Study Start Date : April 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Calcitonin
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 100 iu of calcitonin will be injected epidurally in Bupivacain-Calcitonin-fentanyl (BC) Group,
Drug: Calcitonin
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Other Name: maicalciac

Active Comparator: fentanyl
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Drug: Fentanyl
Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
Other Name: fentavera




Primary Outcome Measures :
  1. visual analogue scale [ Time Frame: 48 hours ]
    The primary outcome of the study the analgesic effects of epidural calcitonin versus opioids administered for patients undergoing lower limb amputation surgery on postoperative pain using combined spinal epidural anesthesia.


Secondary Outcome Measures :
  1. Analgesic consumption [ Time Frame: 48 hours ]
    The secondary outcome of this study is to measure analgesic consumption in patients undergoing lower limb amputation using combined spinal epidural anesthesia.


Other Outcome Measures:
  1. post amputation pain [ Time Frame: 6 months ]
    the development of post amputation phantom limb pain in calcitonin versus opioids administered for patients undergoing lower limb amputation surgery on postoperative pain using combined spinal epidural anesthesia.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • prospective randomized double-blind clinical trial design will be used in a cohort of sixty patients of both genders
  • physical status American Society of Anaesthesiologist (ASA) I and II
  • will undergo lower limb amputation

Exclusion Criteria:

  • history of pituitary gland dysfunction
  • cardiac disease
  • chronic obstructive respiratory disease
  • contraindications to performing an epidural block such as:

    • coagulation abnormalities
    • spinal deformities, and
  • patients allergic to local anesthetics and or calcitonin will be excluded from the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115360


Locations
Egypt
Tanta University Hospitals
Tanta, Algharbyia, Egypt, 35217
Sponsors and Collaborators
Tanta University
Investigators
Principal Investigator: Ayman A Yousef, MD Assistant Professor

Publications:
Responsible Party: Ayman Abd Al-maksoud Yousef, Assistant Professor, Tanta University
ClinicalTrials.gov Identifier: NCT02115360     History of Changes
Other Study ID Numbers: 2308/1/14
First Posted: April 16, 2014    Key Record Dates
Last Update Posted: August 31, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ayman Abd Al-maksoud Yousef, Tanta University:
epidural calcitonin
amputation
postoperative pain
Later Complication

Additional relevant MeSH terms:
Pharmaceutical Solutions
Bupivacaine
Lidocaine
Fentanyl
Epinephrine
Racepinephrine
Epinephryl borate
Salmon calcitonin
Calcitonin
Calcitonin Gene-Related Peptide
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents